clinical trial · NCT05039619
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Obinutuzumab in Adolescents With Active Class III or IV Lupus Nephritis and the Safety and PK of Obinutuzumab in Pediatric Participants
Lupus NephritisObinutuzumabPlaceboMycophenolate MofetilAcetaminophen/paracetamolDiphenhydramine hydrochloride (HCl)MethylprednisolonePrednisone
brief summary
This phase II, randomized, double-blind, placebo-controlled study is designed to evaluate the safety, efficacy and pharmacokinetics (PK) of obinutuzumab in adolescent participants (AP) aged 12 to less than 18 with biopsy-confirmed proliferative lupus nephritis (LN). It will also evaluate open label safety and PK of obinutuzumab in pediatric participants (PP), aged 5 to \<12 with LN.
started
May 12, 2022
primary completion
Jun 15, 2028
completion
Jun 14, 2030
last updated
Jul 2, 2026
official title
A Phase II, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Obinutuzumab in Adolescent Patients With Active Class III or IV Lupus Nephritis, Including an Evaluation of Open Label Safety and PK in a Cohort of Pediatric Patients (Aged 5 to < 12)
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol